Ensuring that high ethical standards are applied to clinical
audit

Summary

Participating trusts occasionally enquire about whether the
subject and methods of data collection by these networks
necessitates research ethics approval. The CCQI collects data
for the purpose of audit and occasionally, for the purpose of
service evaluation with a view to service improvement; it does not
undertake research. Neither clinical audit nor service evaluation,
of the type undertaken by the CCQI, require approval from a
research ethics committee. However, the Centre is keen to
underline its ongoing commitment to conducting its work in a
responsible and ethical manner.

What is clinical audit?

“Clinical audit is a quality improvement process that
seeks to improve patient care and outcomes through systematic
review of care against explicit criteria and the implementation of
change. Aspects of the structure, processes, and outcomes of
care are selected and systematically evaluated against each
explicit criterion. Where indicated, changes are implemented at an
individual, team, or service level and further monitoring is used
to confirm improvement in healthcare delivery”.

Principles for Best Practice in
Clinical Audit, National Institute of Clinical Excellence
(2002)

Clinical Audit is directly related to improving services
against a standard that has already been set by examining:

Whether or not what ought to be happening is happening

Whether current practice meets required standards

Whether current practice follows published guidelines

Whether clinical practice is applying the knowledge that has
been gained through research

Whether current evidence is being applied in a given
situation

Guidance on developing procedures within NHS organisations
for appropriate authorisation and management of research and
related projects, Research and Development Forum, 2005

Table 1 lists the features of research, audit and service
evaluation. The table was devised by the Central Office for
Research and Ethics Committees. COREC’s position is that “Audit
and Service Evaluation, however defined, were recognised to have
no, or less than minimal (risk), and there was broad agreement that
such work need not come before an NHS REC, unless specifically
requested”

Table 1: A table for researchers and reviewers to use
and for the “queries line” to refer to.

RESEARCH

CLINICAL AUDIT

SERVICE EVALUATION

Designed and conducted to generate new knowledge

Designed and conducted to provide new knowledge to provide
best care

Designed and conducted to define current care

Quantitative research – designed to test an hypothesis

Qualitative research - explores themes following established
methodology

Designed to answer the question:

“Does this service reach a predetermined standard?

Designed to answer the question:

“What standard does this service achieve?”

Measures current service against a standard

Measures current service without reference to a standard

May involve a new treatment

Doesn’t involve a new treatment

Doesn’t involve a new treatment

May involve additional therapies, samples or
investigations

Involves no more than administration of questionnaire or
record analysis

Involves no more than administration of simple interview,
questionnaire or record analysis

May involve allocation to treatment groups NOT chosen by HCP
or patient

Does not involve allocation to treatment groups: the HCP and
patients choose treatment

Does not involve allocation to treatment groups: the HCP and
patients choose treatment

May involve randomisation

Does NOT involve randomisation

Does NOT involve randomisation

Under current guidance, research REQUIRES R.E.C.
REVIEW

Under current guidance, audit DOES NOT REQUIRE R.E.C.
REVIEW

Under current guidance, service evaluation DOES NOT
REQUIRE R.E.C. REVIEW

COREC ethics consultation e-group:Audit,
research or service evaluation, Oct 05.

“The taxonomy (Is this work “Research”,
“Audit” or “Service Evaluation”?) was clearly of less concern….than
the consequences for those involved in the
project, particularly patients. It is evident therefore that this
taxonomy is useful but as a surrogate marker for the level
of risk in any project. Audit and Service Evaluation,
however defined, were recognised to have no, or less than minimal,
and there was broad agreement that such work need not come before
an NHS REC, unless specifically requested.”

COREC ethics consultation e-group:Audit,
research or service evaluation, Oct 05.

Discussions between the CCQI and COREC

On the occasions that the CCQI has consulted ethics committees
about its work, their response has confirmed our position.
For example, in February 2006, the CCQI submitted a full
description of the ‘Better Services for People who Self-Harm’
Project to COREC, detailing the audit methods used at the CCQI,
including staff and patient surveys and consultations, the auditing
of case notes and conducting peer-reviews. This included a
list of the questions being put to service users and staff. The
CCQI also reiterated the safeguards it has put in place to protect
the dignity, wellbeing and safety of participants throughout the
audit process. The following reply was received from
COREC:

“Thank you for your query. We have read the
documents you attached and would deem your work to be audit.We agree entirely that audit should be conducted to accepted
ethical standards and your document clearly outlines
this”.

(COREC February 2006).

A similar response was received when the CCQI contacted the
Welsh MREC about the Electroconvulsive Therapy Accreditation
Service (ECTAS) in 2003.

Neither clinical audit nor service evaluation require approval
from a research ethics committee.

The College Centre for Quality Improvement and ethical
audit

The Centre has been running quality improvement programmes
since 1999 and now has ten quality improvement programmes underway
(see table 2). All of the projects managed by the CCQI meet
the criteria listed in the ‘clinical audit’ column above and are
therefore defined as audit, not research.

Table 2: Quality Improvement Clinical AuditProgrammesmanaged by the Royal College of
Psychiatrists' Centre for Quality Improvement

Key features of the CCQI programmes

They do not manipulate treatment plans, or experiment with new
clinical techniques.

They do explore the extent to which services are complying with
nationally agreed standards.

They all share the same long-term aim: to increase compliance
with nationally recognised standards, resulting in an improved
quality of care for the patient group in question.

All of the CCQI projects follow a typical clinical audit
process described in figure 1 below.

Each project has developed its own manual of quality service
standards based on the best available evidence, and collects data
to help services identify aspects of service provision that require
improvement.

The CCQI supports local teams in action planning and re-audits
services periodically, to examine which improvements have been
made.

Services are encouraged to network with each other on a
national or international basis to share ideas for best practice,
helping all services to improve patient care. This is
facilitated by email discussion groups, newsletters, conferences
and learning events delivered by the
CCQI.

Figure 1: The Clinical
Audit Process

Conducting Audit to Accepted Ethical
Standards

Although neither clinical audit nor service evaluation require
approval from a research ethics committee, the CCQI shares the view
that “the dignity, rights, safety and well-being of
participants must be the primary consideration”.

Research Governance Framework for Health and Social Care,
draft second edition, Autumn 2003

Protecting the safety, dignity and rights of
participants (service users and clinicans)

Clinical audit at the CCQI complies with to the Caldicott
principles (1997), the Data Protection Act (1998), the Freedom of
Information Act (2000) and the NHS confidentiality code of practice
(2003).

Potential participants are made fully aware that it is entirely
their choice whether or not they take part in the any consultation
or survey and service users are reassured that choosing not to
participate will not affect the care that they receive in any
way. This is stated clearly in the information provided and
again re-iterated at the beginning of each and every
survey. Participants are reminded of their right to withdraw
from the audit at any stage, without providing an
explanation.

The information sheets provided by the CCQI are written to the
same level of detail as those produced by the Healthcare Research
Team at the College Research and Training Unit (who do have to seek
ethical approval for such materials), so members and participants
can be assured of similarly high quality.

The audits do not ask for any personal identifiers (e.g. name,
date of birth, address).

The anonymity of service users and staff is protected
throughout – views are collated along with those of other
participants, meaning that local teams are unable to identify the
comments or ratings of individual respondents.

Confidentiality and its limits are made clear to all
participants.

Our service user advisors have opined that the level of
distress associated with this work is no more than a satisfaction
survey, and certainly no more than ‘general clinical practice’ –
this is something that COREC have defined as an important
factor. The staff questionnaires were edited by healthcare
professionals.

Consulting with relevant experts

All of the CCQI audits have steering groups consisting of
healthcare professionals and researchers and many also have
extensive service user input. The steering groups play a key
role in planning the work of the audit and ethical issues are
discussed regularly. Where a question arises that appears to
fall outside of the group’s knowledge, specialist expert advice is
carefully sought.

Experienced members of the Healthcare Research Team, based at
the Royal College of Psychiatrists' Research and Training Unit are
available to offer advice about methodology and ethics if
required.

Systematic mechanisms (evaluation forms, discussion groups,
AGMs) are in place to ensure that network members can feed back
their views on the methods being used and raise concerns at any
stage of the process.

All of the projects consult with service users (for example
when writing the service standards) and some employ service users
on the central project team to design service user questionnaires,
and contribute to information sheets and guidance notes. This helps
to ensure that data collection tools do not cause any distress to
participants, and that information provided to service users is
clear and jargon-free.

Conclusion

Although it is clear that the CCQI audits do not fall under
the remit of local or national research ethic committees, the CCQI
takes very seriously its responsibility towards conducting ethical
audit. By putting into place the safeguards mentioned above,
and continually reviewing its practice, the CCQI is confident that
its work would stand up to the scrutiny of any ethical
committee.

Correspondence

Lucy Palmer, Royal College of Psychiatrists’ Centre for
Quality Improvement